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CAR T-cell Therapy
ADCLEC.syn1 CAR T-Cell Therapy for Acute Myeloid Leukemia
Phase 1
Recruiting
Led By Jae Park, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial tests the safety & effectiveness of a new cancer therapy in people w/ relapsed/refractory AML. Researchers will find the highest dose that causes few side effects & test it in a new group of participants.
Who is the study for?
Adults with relapsed or refractory Acute Myeloid Leukemia (AML) who are in good physical condition (ECOG 0-1), have a suitable stem cell donor, and functioning major organs can join this trial. Those with acute promyelocytic leukemia, certain infections like HBV/HCV, other active cancers needing treatment, recent heart issues, uncontrolled infections or previous CAR therapy cannot participate.Check my eligibility
What is being tested?
The study is testing the safety of ADCLEC.syn1 CAR T cells along with conditioning chemotherapy in AML patients. It aims to find the highest dose that's safe with few side effects and then test its effectiveness against AML that has come back or hasn't responded to other treatments.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as fever and fatigue, organ inflammation due to targeted cell destruction by CAR T cells, complications from chemotherapy like nausea and low blood counts which could increase infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
maximum tolerated dose (MTD)
Trial Design
1Treatment groups
Experimental Treatment
Group I: ADCLEC.syn1 CAR T cellsExperimental Treatment2 Interventions
The dose escalation cohort size of 3 patients in each cohort will be infused with escalating doses of ADCLEC.syn1 CAR T cells to inform the RP2D. There are 4 planned flat-dose levels: 25 × 10^6, 75 × 10^6 , 225 × 10^6 , and 450 × 10^6 CAR T cells and 1 de-escalation dose: 10 × 10^6 CAR T cells. After dose escalation, one or two dose levels will be selected for dose expansion cohort(s).Two to 7 days following completion of the conditioning chemotherapy, the frozen CAR T cells will be thawed and administered. Conditioning chemotherapy may occur either outpatient or inpatient, and T cell infusions will occur as inpatient. Up to approximately 12 additional patients each if two doses are selected or approximately 16 additional patients, if one dose is selected, will be treated in the dose expansion phase to determine RP2D.
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,849 Total Patients Enrolled
TakedaIndustry Sponsor
1,203 Previous Clinical Trials
4,177,985 Total Patients Enrolled
Jae Park, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
14 Previous Clinical Trials
445 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not taken clofarabine or cladribine in the last 3 months.My kidney and liver functions are within the required limits.I have been diagnosed with acute promyelocytic leukemia.I have brain-related symptoms or confirmed brain disease.I have undergone CAR therapy before.I have a matching donor for a stem cell transplant.I had a stem cell transplant from a donor less than 3 months ago and don't need ongoing treatment for graft-versus-host disease.I haven't had serious heart issues or uncontrolled infections in the last 6 months.I am not currently taking steroids or chemotherapy.I am fully active or can carry out light work.I am currently being treated for another cancer.I have not received a live vaccine in the last 4 weeks.I am 18 years old or older.My AML cancer has come back or is not responding to treatment.
Research Study Groups:
This trial has the following groups:- Group 1: ADCLEC.syn1 CAR T cells
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can you expand on the security of ADCLEC.syn1 CAR T cells for those receiving medical treatment?
"The safety of ADCLEC.syn1 CAR T cells was appraised as a 1 due to limited evidence related to its efficacy and safety, as it is presently in Phase 1 clinical trials."
Answered by AI
Are there opportunities currently available for prospective individuals to join this trial?
"According to the information found on clinicaltrials.gov, this investigation is not currently enrolling participants; however, it was initially published on February 1st 2023 and last updated a month later. Despite no longer recruiting for this trial there are 1530 other trials actively searching for volunteers at present."
Answered by AI
How extensively has this study been implemented geographically?
"At the moment, this clinical trial is sourcing participants from seven different sites. In addition to Middletown, Montvale and Commack there are four other nearby locations that could be convenient for enrollees. It's important to select a location near you in order to reduce transportation strain if partaking."
Answered by AI
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